“The FDA clearance of CathWorks FFRangio is a significant milestone for interventional cardiologists and the healthcare system overall,” said Jim Corbett, CEO of CathWorks. “It is the first non-invasive device of its kind to receive FDA clearance for use during Percutaneous Coronary Intervention (PCI) assessment. The FAST-FFR study was carried out at 10 centers world-wide and evaluated more than 380 patients. The study demonstrated the clinical predictive value across a full range of coronary physiology, including complex lesion assessment in bifurcations and calcified lesions.